Guest Column
| February 5, 2016

Congratulations! You have an idea for a new medical device that is going to change the world and help lots of people.

You could choose the traditional path of product development: Gather some initial insights, put your head down, and get to work, believing in how smart you are. Or you could employ a different approach, one that engages and involves end-users along the way. One that incorporates the use of prototypes to help you discover what is meaningful and important.

Here are six best practices you can use to help speed up the development of your device while doing it the right way.

1. Set Out To Solve A Real Problem

To me, every medical device should have a single, primary purpose: Improve the quality of life.

Chances are, your medical device product development purpose is tied to improving and saving lives, so this seems very obvious. If your device idea is not solving an actual problem, then market adoption and use is likely going to be very limited at best. If this is the case, how are you improving the quality of life?

If you have an idea, and you think it might solve a real problem, but you are not entirely sure, you have to find out.

Some refer to this generically as market research. In a nutshell, you need to do some digging to determine if your idea is going to be used and accepted by end-users. This involves evaluation of existing products and/or ways the problem is currently addressed. You should also contact prospective end-users of your eventual device. These end-users will provide a ton of insight and value.

2. Know The Regulations

Once you have focused on the specific problem your product will address, you need to define your medical device’s intended use and its indications for use. Intended use is the general purpose, or function, of the device (what you claim the device does); Indications for use describe the disease or condition that the device will diagnose, treat, prevent, cure, or mitigate, as well as a description of the target patient population.

The intended use and indications for use are further expressions of the problem you set out to solve. These items are important because a key part of your product development process will be dictated by knowing how your medical device will be classified by regulatory bodies. That classification is a directly related to the time and money required to bring your product to market.

Minimum viable product (MVP) is a term popularized lately by Eric Ries as part of the lean startup principles. Your medical device product development needs to embrace the concept of MVPs and prototypes: Prototype, learn, iterate, repeat.

Think of your product development efforts comprising several phases, and think of each these phase in terms of its MVPs. Your medical device evolves as you progress through product development. In the beginning, you had an idea or concept — maybe a cocktail napkin sketch or some screen shots. This was your first MVP.

The next stage gets a little more involved, defining intended use and involving end-users, and the MVP becomes more of a proof-of-concept prototype. Developing proof-of-concept MVPs, and putting these in the hands of end-users, will prove invaluable to your product development efforts.

This process continues with each MVP evolving, getting more production-ready at every phase. With each MVP, you should include end-users to provide feedback. This is key for one very simple (and hopefully obvious) reason: These end-users are going to be the champions of your product. Engaging them early and often will help ensure your product’s market success.

There is an old adage that a picture is worth a thousand words. Consider this: A MVP and a prototype is worth a thousand pictures.

4. Design Controls + Risk Management

As you develop MVP after MVP, it is critical that you document what you learn with each version. This is the essence of medical device design controls and risk management.

In the beginning, MVPs guide you toward what is important about your product as it relates to end-users. Capture and document what you learn as user needs.

Once you have a proof-of-concept MVP, use this to help establish and define design inputs. Design inputs are the foundation of your entire product development effort, setting the stage for all future development activities, and directly tying to any design verification (i.e., testing) you plan to do. Use this MVP to help you identify possible hazards. Ultimately, using MVPs will help make your eventual go-to-market product stronger and more risk-averse.

5. Conventional Wisdom Is Wrong

A more conventional and traditional approach to medical device product development goes like this:

Come up with an idea

Put your head down and work toward tackling the technical challenges

Do a whole bunch of testing to prove your concept works

Put a prototype device in the hands of end-users

Cross your fingers

The conventional approach does involve end-users, but much too late in the product development process. The opinions and feedback of end-users are invaluable to the success of your product development effort. Do you want to get this feedback in the middle and latter stages of product development? Or would you prefer to receive this input and feedback from beginning to end?

6. Speed To Market

Medical device product development can go very fast — up until design verification and design validation. These stages are common points where development slows a bit. This is logical, because verification and validation (V&V) often involve a lot of formal testing activities.

Also, V&V is often a point in product development time when expenses start to increase exponentially. Thus, I’m guessing you want V&V to be smooth and somewhat predictable. The best way to achieve this is to slow down in earlier phases of product development. Specifically, spend more time defining design inputs. Design inputs are the key to your success, and MVPs are the key to defining design inputs.

Here’s the big secret: You should be using prototypes to help define your design inputs and, as you are creating those design inputs, you should know how you plan to verify. Furthermore, you should be using those prototypes to conduct “mini” bench tests and evaluations to help establish design verification methods.

About The Author

Jon D. Speer is the founder and VP of QA/RA at greenlight.guru, a software company that produces beautifully simple quality, compliance and risk management software exclusively for medical device companies. He is also the founder of Creo Quality, a consultancy that specializes in assisting startup medical device companies with product development, quality systems, regulatory compliance, and project management. Jon started his career in the medical device industry over 16 years ago as a product development engineer after receiving his BS in chemical engineering from Rose-Hulman Institute of Technology.

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